Individualizing Pharmacotherapy for African American Smokers

University of Kansas

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Drug: Bupropion; Drug: Nicotine patch; Drug: Varenicline Tartrate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03897439

Study0000142310

R01DA046576 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.

Full description

The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations [varenicline (VAR), bupropion (BUP) plus NP, ] based on verified smoking status at Weeks 2 and 6. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.

Enrollment: 392 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non-Hispanic African American
• ≥ 18 years of age
• Smoke 5-30 cigarettes per day (CPD)
• Daily cigarette smoker
• Smoked at current rate for > 6 months
• Verified smoker (CO > 5 ppm)
• Functioning telephone
• Interested in quitting smoking
• Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits

Exclusion criteria

• Use of non-cigarette tobacco products in past 30 days
• Medical contraindications to NP, BUP, or VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; medications contraindicated ; history of clinically significant allergic reactions; history of epilepsy, seizure, head trauma, psychosis, bipolar disorder, eating disorder; unstable panic disorder or depression; active suicidal ideation; treatment for alcohol or drug dependence in the past year
• Use of pharmacotherapy in the month prior to enrollment
• Pregnant, contemplating getting pregnant, or breastfeeding
• Unstable housing (e.g., street, shelter)
• Plans to move from Kansas City during the treatment and follow-up phase
• Another household member enrolled in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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392 participants in 2 patient groups

Usual Care (UC)

Active Comparator group

Description:

196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.

Treatment:

Drug: Nicotine patch

Optimized Care (OPT)

Experimental group

Description:

196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.

Treatment:

Drug: Varenicline Tartrate

Drug: Nicotine patch

Drug: Bupropion